MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO STR MTP PLT,SHT,TI, STRL; BONE FIXATION PLATE

Model Number	LO-PRO STR MTP PLT,SHT,TI, STRL
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a metatarso-phalangeal (mtp) joint fusion surgery the box for the chosen plate was opened and the implant inside wasn¿t the correct one.The outer box was mtp straight, short, ar-8944-ps, lot 11073397.Implant inside was mtp contoured short right ar-8944cr-ps, kit 13922763.The box was sealed at the product label end, but the sellotape seal at the other end was broken.Another ar-8944-ps from the loan kit was used to complete the procedure.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Event description: it was reported that during a metatarso-phalangeal (mtp) joint fusion surgery the box for the chosen plate was opened and the implant inside wasn¿t the correct one.The outer box was mtp straight, short, ar-8944-ps, lot 11073397.Implant inside was mtp contoured short right ar-8944cr-ps, kit 13922763.The box was sealed at the product label end, but the sellotape seal at the other end was broken.The reported event was confirmed as the visual evaluation revealed that the sent items fitting the error description.The outer white packaging shows ar-8944-ps / 11073397 and the inner sterile packaging shows ar-8944cr-ps / 13922763 (see evaluation picture 2 + 3).Also the sellotape seal is torn open (see evaluation picture 5).Further the plate in the sterile packaging is has a different lot number (12839881) than the sterile packaging (13922763) - (see evaluation picture 3 + 4).The most likely cause for the reported failure can be attributed to a manufacturing issue; (packaging/handling).

• Brand Name: LO-PRO STR MTP PLT,SHT,TI, STRL
• Common Device Name: BONE FIXATION PLATE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19563407
• Report Number: 1220246-2024-06023
• Device Sequence Number: 7545034
• Product Code: HRS
• UDI-Device Identifier: 00888867204065
• UDI-Public: 00888867204065
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K150456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: LO-PRO STR MTP PLT,SHT,TI, STRL
• Device Catalogue Number: AR-8944-PS
• Device Lot Number: 11073397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown